FDA Grants Priority Review to Maxamine for the Treatment of Advanced Metastatic Melanoma.

Business Editors/Health & Medical Writers

SAN DIEGO--(BW HealthWire)--Sept. 7, 2000

Maxim Pharmaceuticals (Nasdaq:MAXM)(SSE:MAXM) announced that its lead drug candidate Maxamine(R) (histamine dihydrochloride) has been designated for priority review by the U.S. Food and Drug Administration (FDA).

In July 2000 the company submitted a New Drug Application (NDA) to the FDA seeking approval to market Maxamine in the United States as an adjuvant to interleukin-2 (IL-2) for the treatment of advanced metastatic melanoma. The FDA has informed the company that the NDA has been accepted for review as filed.

Priority review status is granted by the FDA to products that are considered to be a potential therapeutic advance over existing therapies for a life-threatening illness. Generally, the FDA takes action on drugs given a priority review within six months of acceptance of an NDA.

"We are extremely pleased that the FDA has designated Maxamine for priority review and has accepted the NDA for review as filed," said Larry G. Stambaugh, Maxim's chairman and chief executive officer. "There is a great need for more effective therapies for malignant melanoma as this deadly skin cancer is one of the most rapidly increasing cancers in the world. Current treatments for metastatic melanoma often involve substantial toxicity and side effects, may require hospitalization, and have not been proven to result in an increase in survival."

In March 2000 the company completed its U.S. Phase III trial of Maxamine in Stage-IV malignant melanoma. The results show that treatment with the combination of Maxamine and the cytokine IL-2 dramatically improved survival for advanced metastatic melanoma patients with liver metastases compared with those treated with the same doses of IL-2 alone (adjusted p value of 0.008). Treatment with Maxamine and IL-2 improved overall survival, increased survival rates at 12, 18 and 24 months, and improved time-to-disease-progression over treatment with IL-2 alone in all patients.

Results for the Phase III study indicated that treatment with Maxamine and lower-dose IL-2 was safe and well-tolerated and had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved. The tolerability of the Maxamine and IL-2 combination therapy allowed these advanced-stage malignant melanoma patients to treat themselves at home.

Maxamine Overview

Treatment with Maxamine is based upon the discovery of a universal mechanism that suppresses the capacity of the immune system to detect and destroy tumor cells or virally infected cells in many patients with cancer and chronic infectious diseases. Maxamine is designed to reverse this immune suppression, thereby enhancing the effectiveness of immunotherapy, a class of therapies that employ the body's immune system to fight cancer and certain infectious diseases. Maxamine protects critical immune cells and is administered in combination with cytokines such as IL-2 and interferon-alpha, a class of proteins that stimulate these same immune cells. More than 1,200 patients have been treated in the company's completed and ongoing clinical trials in advanced malignant melanoma, acute myelogenous leukemia, hepatitis C and renal cell carcinoma. Maxamine is an investigational drug and has not been approved by the FDA or any international regulatory agency. However, clinical trial results to date suggest that Maxamine Therapy, the administration of Maxamine in combination with cytokines, is a safe, at-home treatment that may improve patient survival.

Maxim Pharmaceuticals is a late-stage biopharmaceutical company developing advanced drugs and therapies for cancer, infectious diseases, degenerative diseases and topical disorders. In addition to the recently completed Phase III trial in stage-IV malignant melanoma, Maxamine is also currently being tested in two additional Phase III cancer clinical trials in 12 countries for malignant melanoma and acute myelogenous leukemia. Phase II trials of Maxamine are also underway for the treatment of hepatitis C and advanced renal cell carcinoma. The company has also developed product candidates based on its MaxDerm(TM) technology that are designed for the treatment of medical conditions for which topical therapy is appropriate such as oral mucositis, herpes, decubitus ulcers, shingles, burns and related conditions. Furthermore, Maxim is developing small-molecule inhibitors and activators of caspases, key enzymes that modulate and carry out the cellular signaling pathways involved in programmed cell death, also known as apoptosis. Compounds that can either inhibit caspases or induce caspases may form the basis for important new drugs for a wide variety of disease targets, such as cancer, cardiovascular disease and other degenerative diseases.

This news release contains certain forward-looking statements that involve risks and uncertainties. Such forward-looking statements include statements regarding the efficacy and intended utilization of Maxamine, MaxDerm and the company's caspase modulator technologies, and regarding Maxim's clinical trials and preclinical development efforts. Such statements are only predictions and the company's actual results may differ materially from those anticipated in these forward-looking statements. Factors that may cause such differences include the risk that the company will not obtain approval to market its products and the risk "that products that appeared promising in early research and clinical trials do not demonstrate efficacy in larger-scale clinical trials. These factors and others are more fully discussed in the company's periodic reports and other filings with the Securities and Exchange Commission.

Note: Maxamine(R), Maxamine Therapy(TM), MaxDerm(TM), and the Maxim logo are trademarks of the company.

Editor's Note: This release is also available on the Internet at: http://www.maxim.com.